K872024 is an FDA 510(k) clearance for the CO2/02 MONITOR MULTINEX. This device is classified as a Analyzer, Gas, Nitrogen, Gaseous-phase (Class II - Special Controls, product code CCI).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 31, 1988, 310 days after receiving the submission on May 26, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1690.
| 510(k) Number | K872024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1987 |
| Decision Date | March 31, 1988 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CCI - Analyzer, Gas, Nitrogen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1690 |